Information provided for informational purposes only

Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

United States Environmental Protection Agency Office of Pesticide Programs

Public Participation Process -- the Final Process
Staff Paper #42

Note To Reader:

Attached is a short discussion about the Pilot Public Participation Process. During the TRAC meeting, EPA and USDA would like to discuss whether this process or some modification of it should be adopted as the final process.

EPA and USDA are actively employing the Pilot Public Participation Process for tolerance reassessment and reregistration of organophosphate pesticides. In the summer of 1998, EPA, USDA and the Tolerance Reassessment Advisory Committee (TRAC) set out to design a process that would increase transparency of regulatory processes and consultation with affected stakeholders by expanding access to risk assessment and risk management processes. At the July 14, 1999 meeting of the TRAC, EPA and USDA announced that one of the public participation process options considered by TRAC would be implemented as a pilot. By piloting a process, EPA, USDA, and TRAC could test whether the process achieved the goals of increasing transparency and consultation. A pilot effort would provide an opportunity to identify issues associated with public release of risk assessments and management documents, and to evaluate how best to obtain public input into the risk assessments and risk management development process.

The Pilot Process has now been underway for one year. During the October 20 - 21, 1999, TRAC meeting, EPA and USDA would like to discuss with the Committee whether this process or some modification of it should be adopted as the final process. Discussion could focus on whether steps in certain phases, and even certain phases, should be modified, eliminated, or expanded because of the experiences of TRAC members, industry, and the general public during the past year under the pilot process. For example, modifications that the Committee could discuss include consolidating some steps and or phases in the process, adopting the current pilot as the final process, modifying and even expanding aspects of certain phases to enhance public involvement or inter-agency governmental review earlier in the process, as well as others options. Also for discussion is whether the current or a modified process should be used for tolerance reassessment and reregistration of pesticides other than the organophosphates.

DRAFT 10/20/99

Public Participation Process Options for the Final Process

EPA and USDA are actively employing the Pilot Public Participation Process for tolerance reassessment and reregistration of organophosphate pesticides. In the summer of 1998, EPA, USDA and the Tolerance Reassessment Advisory Committee (TRAC) set out to design a process that would increase transparency of regulatory processes and consultation with affected stakeholders by expanding access to risk assessment and risk management processes. At the July 14 meeting of the TRAC, EPA and USDA announced that one of the process options considered by TRAC would be implemented as a pilot. By piloting a process, EPA, USDA, and TRAC could test whether the process achieved the goals of increasing transparency and consultation. A pilot effort would provide an opportunity to identify issues associated with public release of risk assessments and management documents, and to evaluate how best to obtain public input into the risk assessments and risk management development process.

The Pilot Process has now been underway for one year and consideration must now be given as to whether this process or some modification of it should be adopted as the final process, and whether it should be used beyond the tolerance reassessment for organophosphates. The following provides a brief description of the process that is now being piloted and an option for a modified process.

Pilot Process (Attachment A)

A very brief summary of the current OP Pilot Public Participation Process is given below. A more complete description is found in Attachment A.

Phase 1: Registrant "Error Only" Review (30 days). EPA sends its preliminary risk assessments to registrant(s) for a 30-day error-only identification period, and to USDA.

Phase 2: EPA Considers Registrants' Comments (up to 30 days). EPA considers error comments from registrants and USDA, and corrects errors in the preliminary risk assessments.

Phase 3: Public Comment on Preliminary Risk Assessment (60 days). EPA publishes a Federal Register (FR) Notice of Availability releasing the preliminary risk assessments and related documents for a 60-day public comment period.

Phase 4: EPA Revises Risk Assessments (up to 90 days). EPA considers stakeholders comments received during the Phase 3 public comment period, develops a revised risk assessment, and sends it to USDA for review. EPA and USDA may host Technical Briefings to share the revised risk assessments with the public.

Phase 5: EPA Solicits Risk Management Ideas (60 days). EPA publishes an FR Notice of Availability releasing the revised risk assessment to the public, and opening a 60-day public participation period during which the public is encouraged to submit risk management ideas.

Phase 6: EPA Develops Risk Management Strategies (up to 60 days). EPA considers all risk management proposals received, and with input from USDA, develops risk management strategies.

Modification of the Pilot Process (Attachment B)

The modified process contains many of the same elements of the pilot process and enhances public participation at important stages.

Pre-Phase 1: Public Engagement.

A significant focus of the process is to engage stakeholders as early as practicable to ensure that the risk assessment reflect actual use and usage, available data, current labeling, and other information on use practices that stakeholders can provide. In the months prior to the formal initiation of the public participation process (which starts with release of the risk assessments to the registrants for error correction), USDA, EPA, and other government agencies (e.g., DHHS and FDA) will work cooperatively to organize SMART Meetings (use/usage discussions) with interested stakeholders and encourage them to share their information with the agencies.

In addition, EPA will inform the public about pesticides that are scheduled for the public participation process. The Agency will name pesticides that will start the process well in advance of the initiation of the process. Registrants will be asked to identify any ongoing studies and analyses that are relevant to the risk assessment, and EPA will announce for each pesticide the due dates for the submission of data, information, and analyses. In this way, the public will be able to prepare for the initiation of the process for pesticides that they may be interested in, including the preparation data and information for consideration by the agencies.

The Agency anticipates that modifications to the standard process will be appropriate for pesticides with limited use and usage, low risk concerns, number of stakeholders, or other factors. EPA will inform the public of modifications to the standard public participation process that are warranted for a chemical. For chemicals that meet these criteria, alterations to the process will most typically include a tailoring of the stakeholder communication opportunities. In addition, upon release of the risk assessment for public comment (Phase 3), a Stakeholder Meeting may be substituted for a formal Technical Briefing.

EPA may issue risk management decisions on certain uses of a pesticide if it is warranted by risk levels identified in the risk assessments. While EPA may exercise this authority at anytime during this process, the Agency will ensure that stakeholders and other government agencies (e.g., USDA, FDA, DHHS) will be informed and involved in the decision-making process through meetings and conference calls.

Phase 1: Risk Assessment Registrant Error-Only Review, Chemical Profile, and Inter-Agency Engagement (30 Days).

Phase 1 of the modified public participation process is the same as the pilot process in that the risk assessments are sent to the pesticide's registrant(s) for error correction, but an increased effort at disseminating information to the public has been added as well as enhanced inter-agency communication. EPA initiates the formal public participation process by transmitting its human health and ecological risk assessments to registrant(s) of the pesticide for a 30-day error correction review. They are asked to identify and correct any computational or other errors that EPA has made in developing its assessment of the pesticide's risks. Registrants will be asked again about due dates for the submission of data and information to EPA, and for an indication of how the study or analysis may change the risk assessment.

In addition, EPA recognizes that the public would find useful for their planning purposes a description of the pesticide that has started the public participation process. The Agency will publish a FR Notice of Availability announcing the release of the chemical's Profile to the Office of Pesticide Program's (OPP) public docket and internet website for a 30-day public comment period. The Profile is a document that characterizes the use, usage, and types of data and information used in the assessments (dietary, ecological, and occupational).

At the same time that the risk assessments are sent to registrants, EPA transmits the assessments and related documents (including the pesticide's Overview that summarizes the risk assessments, and the pesticide's Profile) to USDA, FDA, DHHS for inter-agency review and comment.

Phase 2: Agency Considers Registrant Error Comments (Up to 45 Days)

In Phase 2, EPA summarizes and considers the errors that have been identified by the registrant(s) and makes changes in the risk assessments to correct any errors that are identified, as appropriate. Approximately 2 weeks before the close of Phase 2, EPA will send to USDA a revised risk assessment and Overview. USDA and EPA will organize conference calls with stakeholders to review and discuss the Overview. EPA and USDA will work to address the comments and ideas received during the stakeholder conference calls. EPA will also address risk assessment comments received from FDA and DHHS. By the end of this phase, the risk assessments are prepared for public release. Discussions with the other government agencies on comments and issues will continue throughout Phases 2, 3, and 4 as needed.

Phase 3: Public Participation Period: Technical Briefing, Public Comment on Risk Assessment, and Risk Management Options (90 Days)

Phase 3 provides the public with opportunities for comment on the pesticide's risk assessment and risk management options, and with a Technical Briefing and/or Stakeholder meeting(s). The Phase begins with EPA publishing in the Federal Register a Notice of Availability of the risk assessments and related documents (e.g., Overview, Summary, registrant's error comments, agency's response to comments, Q&A, etc.), and risk management options for a 90-day public review and comment period. All of the documents will be made available in OPP's public docket and internet website.

A public Technical Briefing or Stakeholder Meeting (as appropriate for pesticides with limited use and usage, low risk concerns, number of stakeholders, or other factors) will be held at the beginning of Phase 3 in order to share with the public the revised risk assessments and the range of possible risk management options. In addition, an inter-agency effort will be initiated to engage stakeholders in a dialogue on the risk assessments and risk management options. This dialogue is expected to continue into the fourth phase of the public participation process.

Phase 4: Develop Final Risk Assessments and Risk Management (30 - 90 Days)

In the fourth Phase, EPA reviews and considers the comments, data, and risk management ideas and proposals received during the Phase 3 public comment period and during stakeholder dialogue and meetings. Dialogue with stakeholders will continue through Phase 4. EPA develops the revised risk assessments and, with input from USDA, FDA, and DHHS, EPA develops the risk management documents. An inter-agency senior management briefing will be held to discuss the revised risk assessments and risk management. EPA releases to the public the revised risk assessments and issues the risk management decisions (interim RED/Tolerance reassessment) for the pesticide.

Attachment A

This list provides an overview of the phases of the OP Pilot Public Participation Process, highlighting the opportunities for public involvement, and review and comment on OP documents.

Pilot Process for the Organophosphates

Phase 1 (30 days) -- Registrant "Error Only" Review: EPA sends its preliminary human health and ecological risk assessments to registrant(s) of the pesticide for a 30-day error correction review, and to the US Department of Agriculture (USDA). They are asked to correct any computational or other errors that EPA has made in developing its preliminary assessment of the pesticide's risks.
Phase 2 (up to 30 days) -- EPA Considers Registrants' Comments: EPA summarizes and considers comments from registrants and USDA. EPA incorporates comments or makes changes in the preliminary risk assessments to correct any errors identified. By the end of this phase, EPA opens a Public Docket for the pesticide.
Phase 3 (60 days) -- Public Comment on Preliminary Risk Assessment: EPA publishes a Federal Register (FR) Notice of Availability announcing its preliminary risk assessment, opening a 60-day public review and comment period. Registrants, grower groups, other stakeholders and the public are encouraged to submit data and other information to refine EPA's preliminary risk assessment. They also may begin submitting risk management proposals to address any risk concerns identified in the document. EPA may meet with registrants and other stakeholders to discuss risk related data, use information, and risk assessment/risk management alternatives.
Phase 4 (up to 90 days) -- EPA Revises Risk Assessments: EPA summarizes and considers comments, data, and risk mitigation proposals received during the Phase 3 public comment period. EPA develops a revised risk assessment and sends it to USDA for review. EPA and USDA may host public meetings to share the revised risk assessment with the public and discuss risk management ideas.
Phase 5 (60 days) -- EPA Solicits Risk Management Ideas: EPA releases the revised risk assessment to the public for viewing via the OP Public Docket. EPA publishes an FR Notice of Availability opening a 60-day public consultation period during which risk management proposals are solicited. Registrants, grower groups, other stakeholders and the public are encouraged to participate and submit their risk management proposals. EPA and USDA may meet with registrants and other stakeholders to discuss risk management alternatives and strategies. Meeting minutes will be included in the Public Docket.
Phase 6 (up to 60 days) -- EPA Develops Risk Management Strategies: EPA considers all risk management proposals received. With input from USDA, EPA develops risk management strategies that ultimately will contribute to the Agency's risk management decisions for this and other OPs. Public Participation Process ATTACHMENT B
  Pre-Phase 1  30 Days  Up to 45 Days 90 Days 30 - 90 Days
Public Engagement

The following will occur in the months (e.g., 3-6 months) prior to the start of the Public Participation Process:



* SMART Meetings to clarify use, usage, labels, data that are being used in the risk assessments, and data and information that could be submitted with be held with:

--Registrants

--Major interested stakeholders.



SMART Meetings will be inter-agency efforts (EPA, USDA, FDA, DHHS).



* EPA will announce:

--The schedule of pesticides that will start the process.

--Due date for submission of data and information for each pesticide, based on discussions with registrants & stakeholders.

--The process plan for each pesticide that tells whether the standard process will be followed or altered (based on use & usage, risk levels, number of stakeholders.) Alterations could include a smaller number of stakeholder/SMART

Phase 1

Risk Assessment Registrant Error-Only Review; Chemical Profile; Inter-Agency Engagement



* EPA initiates the Process by transmitting the risk assmt. to the registrant for a 30-day error (only) identification period.



* EPA transmits the risk assessments and their Overview, and the chemical's Profile for inter-agency review and comment (USDA, FDA, DHHS)



* EPA publishes a FR Notice of Availability announcing the release to the public docket and internet of the chemical's Profile for a 30-day public comment period, which characterizes the use, usage, and types of data and information used in the assessments (dietary, ecological, and occupational).



* EPA may issue risk management decision(s) at any time during the process if warranted by risk levels. EPA will ensure that stakeholders & other government agencies (USDA, FDA, DHHS) are informed and involved.

Phase 2

EPA Considers Registrant Error Comments







* EPA addresses errors identified by the registrant in the risk assessment.



* EPA and USDA work to address public comments on the Profile, and EPA addresses risk assessment comments received from other government agencies. Discussions on comments and issues continue throughout Phases 2, 3, and 4 as needed.



* Approximately 2 weeks before the close of Phase 2, EPA will send to USDA the revised risk assessment & Overview, and USDA and EPA will organize conference calls with stakeholders to review and discuss the Overview.

Phase 3

Public Participation Period: Technical Briefing, Public Comment on Risk Assessments and Risk Management Options







* Phase 3 starts with a Technical Briefing and/or Stakeholder meeting(s).



* 90-day public review and comment. Publish FR Notice of Availability in public docket and internet of:

-- risk assessments and related

documents (e.g., Overview,

Summary, registrant's error

comments, EPA's response

to comments, Q&A, etc.)

-- risk management options.



* Initiate inter-agency efforts to engage stakeholders in a dialogue on risk assessments and management. (Dialogue to continue into Phase 4)

Phase 4

Develop Final Risk Assessments and Management







* EPA reviews public and inter-agency comments.



* EPA revises risk assessments and develops risk management.



* Continuation of inter-agency efforts to engage stakeholders in a dialogue on risk assessments and management



* Inter-agency senior management briefing on the revised risk assessments and risk management.



* EPA releases final risk assessments and issues risk management decisions (RED/Tolerance reassessment)


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